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TriPath's p53 breast test analysers:

This article was originally published in Clinica

Executive Summary

TriPath Imaging has received US FDA 510(k) market clearance to use a Ventana-branded version of its interactive histology image analysis system with tissues stained for p53, a tumour suppressor biomarker associated with more aggressive breast cancers. The Ventana Image Analysis System (VIAS) has previously been cleared for use with the Ventana oestrogen receptor, progesterone receptor, Ki-67 and HER-2/neu assays. In 2004, TriPath, of Burlington, North Carolina, gave Tucson, Arizona-based Ventana exclusive rights to sell and distribute worldwide a Ventana-branded version of its imaging system, optimised for both Ventana and TriPath assays. "This is the first time the p53 marker has been cleared by the FDA for use with an image analysis system," said Paul Sohmer, TriPath's chairman, president and CEO.

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